Artificial gastric valve

ABSTRACT

An apparatus and method are disclosed for treating overweight and obese patients by applying a restrictive Artificial Gastric Valve (AGV) on part of the stomach. The apparatus includes a mechanism to control the opening of the AGV automatically on demand, dynamically and progressively. The controlled opening of the AGV inside the stomach controls and regulates the flow of food.

This application claims the benefit under Title 35, U.S.C. §119 (e) ofU.S. provisional application 60/670,546 filed on Apr. 13, 2005, theentire contents of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method and apparatus for treatingobesity, and more specifically the invention relates to an artificialgastric valve that can be implanted in a patient for treating obesity.

2. Description of the Related Art

In the opinion of many health care experts, obesity is the largesthealth problem facing westernized societies and is considered anepidemic. From a medical standpoint, obesity is the primary risk factorfor type 2 diabetes and obstructive sleep apnea. It increases thechances for heart disease, pulmonary disease, infertility,osteoarthritis, cholecystitis and several major cancers, includingbreast and colon. People with Body Mass Index (“BMI”) greater than 40are considered morbidly obese. People with BMI between 30 and 40 areconsidered obese. Most importantly, high BMI has been shown to cause areduction in life expectancy.

From an economic standpoint, it is estimated that more than 100 billiondollars are spent on obesity and treating its major co-morbidities. Thisdoes not even consider the psychological and social costs of thisepidemic problem. Despite these alarming facts, treatment options forobesity remain limited. The desire to eat and the body's counterregulatory system when caloric intake is reduced, makes the treatment ofobesity quite a difficult task.

The obesity epidemic and its medical impact have been well documented.Currently over 50 billion dollars are spent on over the counter weightloss products and programs. The number of invasive surgical proceduressuch as gastric bypass and lap band being performed for severe obesityis rapidly increasing. In the past 5 years there has been a 450%increase in surgical procedures for obesity. On average these procedurescost more than $25,000. Furthermore, the complicated nature of theseprocedures and potential for negative long term effects make only themost obese candidates for these procedures. Despite the efficacy ofcurrent surgical procedures, there is a large opportunity to vastlyimprove their effectiveness and limit their complications. It is only inthe last several years, that a majority of health care providers viewedobesity as a disease that justified invasive and aggressive management.The data for the negative impact of obesity on health is nowoverwhelming. Current procedures are merely first generation approachesand have not made an overall impact on obesity treatment and prevention.Consequently, there is a large market opportunity for medical devicesthat better understand the pathophysiology of obesity.

With over 60% of the United States Population obese or overweight,market size is limited only by the development of safe and effectivetechnology. Currently, 150,000 bariatric cases are performed in the US.Approximately, 30,000 are lap bands. At present, staplers and medicaldevices for obesity are approximately a 500, million dollar market. Thisdoes not include the 50 billion dollars spent on weight loss productsand programs. Nor does it include the estimated 100 billion dollar costtreating the complications of obesity. With the large discrepancybetween need and effective treatments, most analysts believe that theobesity market could rival the cardiac stent market if proper devicesare developed. The devices developed to date all have issues.

Gastric Bypass

Gastric Bypass is the most common surgical procedure performed to treatmorbid obesity. The procedure involves using a stapler that cuts anddivides tissue. This is used to produce a pouch that serves as a smallerstomach. This pouch is attached to a limb of divided intestine. Finally,intestinal continuity is restored by attaching the intestine to theintestine.

Numerous things happen when a gastric bypass is performed. The newstomach is smaller and holds less food. Food goes directly into thesmall intestine, bypassing the bottom portion of the stomach and theinitial area of the intestine. Food does not mix with the digestivejuices from the liver and pancreas until a large potion of the GI tracthas been passed. As a result, the operation makes people eat less andcauses impaired absorption of food, minerals and vitamins.

While effective, the bypass can cause numerous long term issues. Thereis a real mortality rate associated with the procedure. Poor ironabsorption can cause anemia. Poor calcium absorption could causeosteopenia. Poor vitamin absorption can cause deficiency in Vitamin A,D, or thiamine. Additionally, there is a risk of marginal ulcer,stricture, and other morbidity.

For these reasons, the number of patients seeking gastric bypass appearsto have stabilized. For the last five years, growth has beenexponential. Currently, patients are searching for the efficacy ofbypass without the potential complications.

Besides the standard gastric bypass, there are other procedures that aresimilar. They include banded bypass, bilio-pancreatic diversion withduodenal switch and Scopinaro procedure. All combine some gastricalteration with an intestinal bypass. All offer weight loss. But allhave a short and long term complication profile that preclude them frombeing considered ideal treatments.

Presently, all these procedures can be performed laparoscopically. Whilethis offers faster recovery, reduced pain, and lower risk of herniaformation, it does not eliminate the short and long term complicationsassociated with gastric bypass.

Laparoscopic Adjustable Gastric Banding

The purpose of the gastric band is to create a narrowing in the proximalstomach that functions as a valve. The valve reduces the space availablefor food in the stomach and delays the emptying of the stomach. Thishopefully makes people eat less and want to eat less frequently. Theband can be tightened with the insertion of liquid through a port thatis placed beneath the skin. New generations will offer band inflationwithout an invasive needle stick. However, the outlet would still remainfixed and the band would still represent a high pressure zone.

The attraction of the band includes its low peri-operative morbidity andmortality. Since there is no alteration of the GI tract itself, recoveryis rapid. However the fixed high pressure zone leads to numerous issues.

Certain patients never achieve an acceptable level of weight loss. Whenthe band is tightened to enhance effect, there can be dilation of thepouch above the band and the esophagus. Patients complain ofregurgitation and dysphagia. Also the high pressure that is transmittedproximally causes a stomach that is more resistant to distension and theforces caused by food bolus.

Several companies are expected to enter the LAGB market. Ethicon Inc, adivision of Johnson and Johnson is expecting approval of there obtechband in 2007. Additionally they have accumulated IP that involvesimproved design including self adjustment. Other band companies inEurope include Mid-Band and Helioscope. A new entry is Endo-Art whichoffers an improved method of non invasive band adjustment.

Gastric Balloons

A simple concept to reduce food intake is the placement of a spaceoccupying balloon. These are inserted with the help of an endoscope. Theballoon is inflated to 600 to 850 cc. This occupies a large portion ofspace in the stomach and leads to early satiety.

There are numerous issues that have limited the clinical usefulness ofballoons. The harsh acidic environment of the stomach can causedestruction of the balloon. As a result, the balloon needs to bereplaced every six months. More importantly, the large balloon causesthe stomach to reset. Since there is no external restriction the stomachcan dilate. In fact the stomach can dilate to quite extreme levels. Asthe volume of a sphere changes with the radius to the third power, evena small level of dilatation can lead to an impressive increase in thesize of the gastric reservoir.

As a result, most view balloons as a bridge for very high risk patients,to more efficacious treatment modalities, such as gastric bypass. Oldversion of the balloon such as the Taylor or Guerin balloons wererecalled from the market. Bioenterics, the maker of the lap band hasre-introduced the Bioenterics intra-gastric balloon, with their improvedsilicone.

Gastric Pacing

There are several investigational designs that have explored usingelectrical stimulation with the use of a pacemaker to either the gastrictract or essential nerves. The most investigated is trans gastric pacingutilized by Transneuronix, which was recently purchased by Medtronics,for a minimal value of 260 million dollars. With incentives, the dealcould be worth one billion dollars.

This approach involves the insertion of electrical leads on the lessercurvature of the stomach, close to the fibers of the vagus nerve. Theseleads are attached to a pacemaker.

There are numerous theories regarding the effect of gastric pacing. Theoriginal hypothesis was that the pacing interfered with the normalelectrical system of the stomach and caused a delay in gastric emptying.This delay would allow the stomach to stay full and reduce foodingestion. Unfortunately, gastric emptying studies failed to showconsistent delay in gastric emptying. More recent theories involvestimulation of enteric nerves, and local hormonal factors.

Several large trials that have included sham arms have investigated theefficacy of gastric pacing. To date, they have not shown consistentefficacy. Recently, Medtronic announced that the most recent trialfailed to demonstrate weight loss.

Another version using similar technology is being employed by ImpulseDynamics which is a privately held Israeli based. In their system,impedance is measured and the gastric pacing is linked to a change inimpedance. Clinical trials are being done in Vienna and the USA.

Cyberonics Inc. has investigated the use of vagus nerve stimulation forobesity. Favorable animal data lead to a six patient clinical pilot.Results were similar to what was reported by Transneuronix. Two patientsdid well, two had limited efficacy and two had no effect at all. Theconclusion was that there was a real effect, but that more investigationwas needed to master the needed signal.

Leptos, a new start up is investigating the use of splanchnic nervestimulation. Similar to the vagus nerve, the splanchnic nerve is aconduit for information from the stomach and intestines to the brain.Promising animal data has been generated and pilot human trials areplanned. Leptos has completed a second round of financing at a valuationof 12 million dollars.

Perhaps the most futuristic approach is being developed by Intrapace.Their approach is to design an internally placed pacemaker that isinserted through a trans-oral approach. In addition to all the unknownsthat the other stimulation products have, this approach adds newdimensions. They include the need for a small or rechargeable battery,limited space, the harsh gastric environment and the difficulty ingenerating the high power signal believed necessary to stimulate small Cfibers.

All pacing concepts are based on stimulating the intrinsic wiring of thestomach and mimic what happens when the stomach is stimulated by theingestion of food. The problem is that while we know that this wiringexists, we do not know the morse code needed to decipher. The pacersgenerate an electrical signal that goes on or off. There is no crescendoor decrescendo response. Only Impulse Dynamics tries to overcome thisobstacle. Additionally, there is no physiologic response to titrate theresponse. Thus only expensive clinical trials can be performed to see ifthe pacing is effective. The Transneuronix experience highlights theseissues.

Many patients lost weight in their clinical trial. However, whencompared to placebo the response was not statistically significant.Other, than repeat an entire trial with different pacing parameters or apatient selection, there is little that can be done. Basically, improvedparameters will need to be guessed and only a lengthy trial willdetermine whether effective.

Pacing strategies are attractive since they would be low riskprocedures. However, they will be expensive and efficacy may provedifficult. Contrary to cardiac pacemakers, there is no short term way ofdetermining whether you have achieved your clinical objective. As aresult, improvements will be difficult to prove.

Other hurdles besides clinical approval, will be gaining reimbursement.These devices will be expensive and require battery change at regularintervals. Even if FDA requirements for pre-market approval are met, itwill be a long time before reimbursement is obtained from a majority ofcommercial insurance plans. Furthermore, approval for Medicarereimbursement will be difficult. The expense of these devices and thecost of invasive implant and the need for battery change will reduce thenumber of potential self or cash pay recipients.

Endoscopic or Trans Oral Restriction or Sleeves

Trans-oral approaches offer the potential to have access to the GI tractwithout incision. Theoretically, procedures could be done in anoutpatient setting without general anesthesia or endotrachealintubation. These approaches could limit morbidity and make thedevelopment of sepsis, wound breakdown and fistula less likely. Finally,the potential reduced cost of outpatient procedures could make treatmentmore affordable.

There is an extensive list of trans-oral approaches that are beingdeveloped. These include oral devices, bezoars that occupy space in thestomach, internal suturing devices, stents and grafts that serve as aconduit for food bypassing areas of caloric absorption, gastric clampingor fusion techniques, radiofrequency ablation and intra gastric pacing.At present, an oral device and a balloon that occupies space have beenutilized in clinical practice. Endoscopic suturing has been done forgastric fistulas and dilated gastrojejunostomy attachments withpromising early results. Suturing has also been done as a primaryprocedure for obesity in South America.

Oral Devices

The concept of an oral device is to occupy the space under the roof ofthe mouth. This forces patients to take smaller bites, eat slowly andhopefully eat smaller meals. The device, called the DDS, (ScientificIntake) is inserted by the patient prior to eating and removed at theconclusion of the meal. Each person has an impression produced and thedevice custom made. A recent modification allows for a chip to beinserted to check for compliance.

At present the device has been utilized by over 3000 people. There areno reports of any significant adverse events. An acute study performedat Pennington Institute revealed that the study group eat 23% less foodand this was associated with a six pound weight loss. A multi-centeredFDA trial was scheduled to begin in January of 2006, to objectivelystudy the device and the compliance pattern of patients.

The future market of this device is not designed to be competitive withthe companies products. This approached is being advocated as a firstline and for those with minimal obesity. For success there will need tobe compliance and extensive behavior modification will be combined withthe oral device.

Internal Suturing and Gastric Clamping

Several approaches are being designed to reduced the size of the stomachand perform an internal restrictive obesity operation. The idea is toreduce gastric capacity similar to what is done with a vertical bandedgastroplasty. Several established and startup companies are examiningthese techniques. They are attempting to utilize either a combination ofa suturing device and methods that fuse the walls of the stomach.

Satiety Inc. a privately held start up, which has an approach tointernally reduce the size of the gastric reservoir. They are developingtissue fusion and suturing device to accomplish this goal. There areseveral major issues. First there is the technical challenge ofdesigning an endoscopic product that fits through a currently availableendoscope or overtube to perform the procedure. Furthermore, ifaccomplished the durability of these procedures will have to bequestioned. Staple breakdown rates of 10-20% have been reported forexternally applied staplers. How internal sutures or fusion techniqueswill hold in the acidic gastric environment, remains to be determined.Furthermore, in open procedures, unless these procedures were reinforcedwith synthetic bands, they had very short term efficacy. Another majorquestion will be the regulatory path and follow up period that the FDAwill find acceptable. If more than one year of follow up is required,these durability issues may prove terminal.

Gastric Sleeves

Another technique to reproduce the benefits of a gastric bypasstransorally are gastric sleeves or elephant trunks. The idea is toutilize a graft, that is anchored to the GI tract by an attachmentdevice such as a stent. The graft would be lodged into the jejunum orproximal ileum. Food would travel down the conduit, not mixing with thedigestive enzymes and reduce small bowel absorption. This couldpotentially be combined with a gastric restrictive device to imitate agastric bypass. Others have also proposed combining such a techniquewith an Adjustable Laparoscopic Gastric Band.

Numeorus start up companies that have raised capital at valuationsapproaching 20 million dollars, have taken this approach. They includeGI Dynamics, Barosense and GastroRx.

Issues with sleeves or conduit procedures include, difficulty infixation, potential for obstruction and kinking, migration and anunknown effect on food consumption. As food is in reduced contact withintestinal mucosa, this could actually stimulate recipients to eat moreto compensate.

Insertion of foreign bodies into the gastro intestinal tract isdifferent than placing stents into the vascular system. There are strongmuscular contractions called peristalsis that drives food down theintestinal tract. These forces will make these devices difficult toanchor. Thus they will migrate and kink and cause intestinalobstruction. Additionally, the graft will serve as an absorber of thetransient pressure increases seen with food consumption.

These devices will have to overcome all these technical barriers. Oncethese are overcome, then efficacy will need to be determined. Thesedevices have no real precedent surgical procedure to predict their longterm effectiveness and durability.

Most Common Techniques

The most common operation in the United States is the Gastric Bypass.With gastric bypass many investigators have reported weight loss resultsthat exceed 70% of excess weight. However, this efficacy does not comewithout complication. The accepted mortality of the procedure is 1 in200. Even higher figures have recently been reported among beneficiariesof medicare. Furthermore, there is an increasing recidivism rate. Weightgain of 10 to 40% of maximum weight loss has been reported. Immediatelyafter surgery, most patients report less desire to eat. Unfortunately, 6to 12 months after surgery the urge to eat seems to return. Most, stillcannot eat the portion size they once consumed. However they replacethis with eating small amounts of calorically dense foods more often.There can be expansion of the pouch and dilation of the attachmentbetween the stomach and the intestine.

Another view, is that the operation is fixed and unlikely to work betterthan immediately after it was performed. As the patient challenges theprocedure, the tissue changes to allow more food to enter. The negativereinforcement the operation offers decreases over time. We learn what toeat, how to eat it and sub consciously learn tricks that allow us toreturn to the habits that made the patient obese.

Other common techniques include the lap band or adjustable gastric bandswhich have similar limitations. The band is a synthetic medical devicethat can be thought of as a ring that goes around the first portion ofthe stomach. Inside the ring is an inflatable balloon. This balloon canbe tightened by inflating fluid that makes the outlet of the stomachsmaller.

The purpose is to make the recipient eat less food and smaller portions.While the lap band is adjustable this does not change the fact that therestriction is fixed. The lap band creates a high pressure zone thatdelays food intake past this point. This high pressure is transmitted toall places above the band. This can lead to dysphagia, dilatation of thestomach and esophagus above the band, regurgitation and reflux.Furthermore, the persistent high pressure would make it more difficultfor a limited bolus of food to initiate satiety signals. While early,research has shown that ghrelin (a hormone that has been linked tosatiety) levels stay persistently high in lap band patients. Low ghrelinlevels have been reported in post bypass patients and are thought to bepartially responsible for the post operative anorexia experienced bypatients.

The advantages of the lap band, compared to gastric bypass are multiple.The gastrointestinal tract does not have to permanently altered. Thereis no malabsorption of vitamins and minerals. The operative morbidityand mortality is much lower. On the other hand, results are morevariable. 10% of recipients have minimal weight loss. Secondary to poorweight loss or other symptoms caused by the fixed obstruction, there-operative surgical rate is also approximately 10%.

As stated above, it is estimated that up to 60% of the population in theUnited States is obese or overweight. Of these patients, 5-6% areconsidered morbidly obese because they are approximately 50 kg abovetheir ideal body weight. Treatment options include dietary modification,very low calorie liquid diet, pharmaceutical agents, counseling,exercise programs and surgery. Surgical procedures that restrict thesize of the stomach and/or bypass parts of the intestine are the onlyremedies that provide lasting weight loss for the majority of morbidlyobese individuals. Surgical procedures for morbid obesity are becomingmore common based on long-term successful weight loss result. Increaseawareness regarding the dangers of obesity combined with the fact thatthese procedures are now being done with a laparosope, in a minimallyinvasive manner, have made these procedures one of the fastest growingareas of surgery.

The surgeries which create malabsorption, such as the by-pass operation,although effective in weight reduction, involve permanent modificationof the GI tract and have a risk of short and long term complication andeven death. A method to create restriction of food flow in the stomachinvolves a device called gastric band in which a band is tightenedaround part of the stomach. The band operation does not modify the GItract at the time of surgery, however because the restrictive band isfixed in diameter, it can create long term complications. The fixed highpressure caused by the obstruction is transmitted to the gastroesophageal junction and esophagus. These structures are forced toaccommodate this increased load. This can result in adaption of thepouch, esophageal dysfunction, and severe dysphagia. At present, only50% of band recipients have what is considered a successful bariatricprocedure. Annually 5% of patients require revision or band removal.Present day gastric bands are fixed in diameter with the ability tochange the diameter via injection of liquid into a balloon. This type ofdiameter change involves a visit to the physician and is not dynamic.Thus people develop gastric pouch dilation, stoma obstruction, motilitydisturbances (pseudo achalasia), esophagitis and other symptoms relatedto a fixed barrier in the stomach.

This review of the obesity device field, emphasizes the need for abetter surgical device for the treatment of obesity. The desired devicewould need to be easily placed. It would need to be reversible. It wouldneed to make people eat less feel less hungry. It would need to beactivated when it is needed, not be locked in the on position. It wouldneed to be able to be altered to meet changing clinical needs.

SUMMARY OF THE INVENTION

The present invention relates to a device which automatically,dynamically and progressively controls the stoma opening by using anArtificial Gastric Valve (“AGV”) that is placed around part of the GItract, preferably around the upper part of the stomach. The AGV canchange its inside diameter on demand and thereby when the diameter ofthe AGV is reduced the stomach is compressed and a restriction of theflow of food in the stomach is created. Similarly, when the diameter isincreased the stomach is relaxed to its natural state.

The change of diameter of the AGV which creates a change of diameter ofthe stomach and therefore restricts the flow of food occurs at timeswhich are a function of start of food intake or other bodily actionstaken by the patient consciously or unconsciously in relation to thestart of eating. When the patient starts eating, a sensor senses one ormore of the bodily actions that are taken immediately after start ofeating such as for example receptive relaxation, esophageal relaxationnear the GE junction as a result of a bolus of food going down to thestomach or the expansion of the stomach at the point where the AGV islocated. The indication of start of eating causes the AGV diameter toreduce thereby constricting the stomach and restricting the flow offood. After eating, the AGV relaxes to its natural state and the stomachis relaxed back to its original condition. The range of variation in theinside diameter of the AGV can be from the natural diameter of thestomach down to a diameter of about 0.3 to 1 cm which amounts to almosta complete closure of the inside of the stomach. The device augments thenatural body response to eating and creates a satiety feeling inaddition to the main progressive restrictive effect which prevents thepatient from excessive eating and causes weight loss without the sideeffects of a fixed diameter gastric band. The opening and closing of theAGV can be titrated to the individual patient by programming thesoftware in an electronic controller. This will also have a block outfeature, preventing too frequent activation and repetitive activationduring the same time period. Additionally, the memory function willallow for the physician to understand how frequently the patient iseating.

The proposed system consists of an AGV padded on the inside to preventerosion of the stomach tissue, a restrictive mechanism for reducing andincreasing the inside diameter of the AGV, a sensor indicating start ofeating and an electronic controller including an algorithm forautomatically deciding on changing the diameter of the AGV, a powersource based on a battery and possibly a remote charging system forcharging a rechargeable battery. All of the parts are insertedlaporascopically into the body. On the outside of the body it ispossible to have a control unit for communicating with the controller 5in the body in order to collect pertinent information and to modify thealgorithm by re-programming the software in the controller. In additionthe part of the remote charging system and its energy supply are on theoutside.

The proposed device being on demand, dynamically and progressivelyconstricting the flow of food where most of the time the AGV is relaxedand the stomach is at its natural state, prevents major problemsassociated with constant restriction of gastric bands and therefore willprevent patients from additional operations and need to take out theimplanted AGV. Problems associated with constant diameter gastric bandsinclude gastric pouch dilation, stoma obstruction, motility disturbancessuch as pseudo achalasia, esophagitis and other symptoms related to afixed barrier in the stomach. In addition, letting the stomach return toits natural state ensures a more natural feeling of satiety not affectedby adaption of the stomach wall to fixed high pressure.

The present invention offers the combination of augmentation of satietywith the known effectiveness of gastric restriction. As the namesuggests the approach is as logical and simple as ABC and has a fargreater chance for long term success than the competition. The system isbased on the lessons the founders have learned with open, laparoscopicand experimental pacing procedures. It is based on the understanding ofthe proximal gastro intestinal tract. As the device employ externalrestriction, it is believed that the path for regulatory approval andreimbursement will be more predictable than other start up firms in theobesity sector.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a block diagram of the AGV of the present invention.

FIG. 1 b is an illustration of the AGV positioned with respect to thestomach.

FIG. 2 a is a schematic top view of the AGV.

FIG. 2 b is a schematic side view of the AGV.

FIG. 3 is an illustration of a mechanical embodiment of the presentinvention.

FIG. 4 is an illustration of a embodiment of the present invention thatincludes a piston.

FIG. 5 is an embodiment of the present invention that includes a liquidreservoir and pump.

FIG. 6 is a drawing of the present invention disposed within the humanbody.

FIG. 7 is a drawing of a sensor disposed on a tooth.

FIG. 8 is a flow chart of a first control algorithm.

FIG. 9 is a flow chart of a second control algorithm.

FIG. 10 is a flow chart of a subroutine for programming the controllerof the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND METHODS

The present invention relates to an Activated Bariatric Concept (“ABC”)which is based on the insight gained by treating thousands of bariatricsurgical patients and performing an equal number of procedures. Eatingbegins with the passage of a bolus of food into the esophagus. Thisbolus travels with the aid of peristaltic forces that are locallygenerated towards the stomach. At the junction of the esophagus and thestomach there exists a valve called the lower esophageal sphincter. Thisvalve relaxes to allow food to enter. The stomach, which sits in arelaxed position, changes to allow food to enter. At the level of thefundus there is receptive relaxation. This means that the wall of thestomach relaxes to allow the food that is entering the stomach to causea smaller increase in pressure.

Humans eat in a certain pattern. At first they eat rapidly. Then thepace slows as the stomach fills and the amount of distension andpressure on the stomach increases. These incremental forces createsignals that travel from the stomach to the central nervous system andgive the feeling of fullness and satiety. Past a certain point they maycause a feeling of bloating and discomfort. These gastric forces, arethe bodies strongest satiety signals. This point is highlighted by thespeed we begin our meals, followed by slower eating, until mealcessation.

The purpose of the present invention is to augment the natural responseof the body. The object of the present invention is to sense theinitiation of food consumption and provide alteration of the gastrictract that mimics what occurs when a person begins to eat. Thus at theorigin of eating a powered device is activated that constricts one areaof the stomach and allows expansion and distension of other areas. Theresult is to both physically restrict the amount of food that is eaten,as well as promote the satiety signals that are produced when distensionor increased pressure in the gastric lumen occurs. This unique approachalso times the signals to coincide to the period when the body is mostreceptive.

The preferred embodiment of the present invention includes an externallyplaced gastric constrictor that is attached to a power source andsensing arm. As the constrictor tightens, the area above will distendand a smaller amount of food will cause a transient rise in pressure inthe proximal stomach. The purpose is to augment what occurs in the rapideating period. Furthermore the proximally placed constricting ring orvalve will limit the reservoir available for food intake. This systemwill combine gastric restriction, and augment satiety.

A further modification could include a trans orally placed internalsystem that will be lodged into the lumen of the stomach. This systemwill be anchored to the gastric wall and distend when stimulatedoccupying space and placing stretch on the gastric wall. Contrary toballoons, this system will exist in the relaxed position thus preventinggastric accommodation.

The purpose of the present invention is to place an artificial valve onthe stomach and preferably at a much higher level of the stomach than isconventional in the art. The valve begins to tighten when wet swallowingor eating commences. This provides progressive gastric restriction,limits food intake and promotes early satiety. The valve graduallyloosens providing controlled emptying of the stomach and causing reducedhunger. The dynamic nature of the valve will prevent long term motilityand esophageal dilation.

The present invention includes a device that augments the naturalresponse of the body to eating and reduces food intake. The device ispreferably referred to as an Artificial Gastric Valve (“AGV”) based onprogressive physical restriction of part of the gastrointestinal (GI)tract, preferably the stomach, with the restriction being controlled bythe initiation of food intake. During periods when food is not beingingested, the device is left in the relaxed position. Thus permanentderangements in esophageal and stomach anatomy and function would not beexpected.

Referring now to FIG. 1 a, a block diagram illustrates the device, andit is divided into portions that are either inside the body or that areoutside the body. The method of operation is hereby described accordingto FIG. 1 a. An AGV 2 made of semi rigid material or thin metal strip,is disposed around the upper part of the stomach 1 in perpendicular tothe vertical disposition of the stomach 1 so that the inside diameter ofthe AGV 2 is in contact with the outer part of the stomach 1 at theposition where the AGV 2 is encircling the stomach.

A preferred position of the AGV is shown in FIG. 1 b. Initially the AGVis open wide enough so that it does not exert pressure on the stomachand therefore does not create a restriction on the flow of food throughthe stomach. Attached to the AGV 2 is a two directional restrictivemechanism 3. The restrictive mechanism 3 is capable of constricting theAGV 2 as well as relaxing it. The restrictive mechanism 3 is capable ofprogressively reducing the inside diameter of the AGV 2, creating apressure on the stomach so that the diameter of the stomach is reducedand the flow of food through the stomach is restricted. A sensor 4 iscapable of sensing the bodily reactions to the start of food ingestionand to send a signal indicating start of eating to a controller B 5.

The controller B 5, using an algorithm 5 a, upon receiving the signal ofstart of eating from the sensor 4, sends a signal to the restrictivemechanism 3 to operate, reduce the diameter of the AGV 2 and create arestriction on food flow. As a result the patient is prevented fromeating excessively. After the patient stops eating, the controller B 5sends a signal to the restrictive mechanism to relax and allows thestomach 1 to get back to its original diameter and natural state. Thecontroller B 5 is using the algorithm 5 a to decide on the time betweenstart of eating and close of the AGV 2, the rate of closing the AGV 2and the extent to which the AGV 2 is closed. Similarly the controller B5 decides on how long after start of eating the AGV 2 opens, at whatrate of opening and to what extent. It is also possible for the sensorto indicate stop of eating for use in deciding when to open the AGV 2and to what extent. The algorithm 5 a can be designed and individuallyadapted to the patient based on his or her eating habits and anatomy.The algorithm 5 a can be modified from outside the body by wirelesssignals from controller A 9 disposed outside the body to controller B 5inside the body. Also, controller A 9 can receive information fromcontroller B 5 via bi-directional wireless communication to allow thephysician to collect data and information on the times of operation ofthe restrictive mechanism 3. The physician can modify the algorithm 5 ato allow the patient more or less freedom to eat by changing the time atwhich the restrictive mechanism 3 starts to operate after the patientstarts to eat, the rate of opening, the extent of opening and the timethe mechanism 3 relaxes the AGV 2, the rate of relaxation and the extentof relaxation. The controller B 5, restrictive mechanism 3 and sensor 4for start of eating receive electrical power from a power source such asa battery or power source 6. If needed, such battery can be chargedusing a remote charger A 8 which inductively transmits energy to chargerB 7 for charging such battery.

The algorithm 5 a preferably includes at least two embodiments asillustrated in the flow charts of FIGS. 8 and 9. In the embodiment ofFIG. 8, the algorithm 5 a controls the AGV 2 in accordance with an inputsignal from a sensor 4. When there is an input signal from the sensor 4,the AGV 2 is constricted in accordance with stored parameters and thetiming of the constriction is stored in the memory of either controllers5,9. The relaxation of the AGV 2 is also controlled in accordance withthe input signal from the sensor 4 and stored parameters. In theembodiment of FIG. 9, the algorithm 5 a controls the AGV 2 in accordancewith arbitrary times that are programmed into the controllers 5,9. Thesearbitrary or predetermined times correspond to time periods when food isexpected to be ingested. When the arbitrary time occurs, the AGV 2 isconstricted in accordance with stored parameters and the timing of theconstriction is stored in the memory of either controllers 5,9. Therelaxation of the AGV 2 is also controlled in accordance with arbitrarytimes and stored parameters. If desired the relaxation of the AGV 2 maybe delayed by a predetermined time period determined by a physician. Thestored parameter are programmed into the controllers 5, 9 in accordancewith the subroutine illustrated in the flow chart of FIG. 10. It is alsopossible that the AGV 2 may be constricted and relaxed in accordancewith input from the sensor 4 and at arbitrary or predetermined timesprogrammed into the controllers 5, 9.

The AGV 2 without the restrictive device 3 is shown in FIG. 2 a and FIG.2 b. The AGV 2 is originally made of a long strip 10 shown in a top viewhaving a predetermined length and width, made of semi rigid material,with ends 11 and 12 that connect to each other. The connection of thetwo ends could be with a buckle or a snap-on or other method to form aclosed loop for embodiments in which the outer diameter of the AGV staysconstant, or could be of a different type connection, such as connectingdirectly to a motor for other embodiments in which the outside diameterof the AGV changes during operation of the AGV. The length and width ofstrip 10 are approximately 10 cm and 1-5 cm respectively. A side view ofside 13 of the AGV 2 is shown in FIG. 2 b. The inside of the strip 10 ispadded with a cushioning material 14 that prevents erosion of thestomach tissue as a result of restricting and relaxing the stomach bythe AGV 2. The material can be soft material in one preferred embodimentand could be a balloon filled with liquid or gas in other embodiments.The balloon could be sealed, or could be connected to a source of liquidor gas and a restrictive mechanism inflates or deflates said balloon ondemand.

The AGV 2 is inserted into the body laporascopically, disposed aroundthe stomach and the two ends of the strip 10 are connected together tocreate a closed loop, leaving the soft cushioning portion 14 in contactwith the stomach tissue.

The sensor 4 for start of eating relies on a known clinical fact thatthe process of start of eating is responsible for a series of bodilyactions such as receptive relaxation of the stomach, saliva secretion,chewing, swallowing, secretion of hormones, change in blood glucoselevel, change in heart rate variability, expansion of the stomach andmore. The sensor 4 for start of eating senses one or more of such bodilyactions. In one preferred embodiment the receptive relaxation of thestomach can be sensed by strain gauges attached to the outside of thestomach or by sensing the electrical signals associated with receptiverelaxation. Such signals can be measured with electrodes attached to theoutside wall of the stomach or by electromagnetic sensors in a waysimilar to the method of cutaneous Electro Gastro-Graphy (EGG). Theelectromagnetic sensing can be done inside the body, or can be donecutaneously and the results can be transmitted to controller A 9.

Since the purpose of the artificial gastric valve 2 is to turn on thesystem at the initiation of food ingestion, it is preferable to utilizea sensing mechanism that determines that a person has started to swallowfood or liquids. As shown in FIG. 7, the sensor 4 can be placed in theoral cavity and be designed to detect the pressure of mastication orother oral signal. The sensor can also be placed at the level of theesophagus and can be internally placed by endoscopy to sit on themucousa. Alternatively, the sensor 4 can be placed around the GEjunction and detect pressure change, motion, or expansion of this areawith the passage of a bolus of food. The sensor 4 could be placedanyplace within or external to the GI tract, with the purpose ofactivating a system that either constricts or distends the stomach.

The sensor signal can include an ultrasound, infrared, electrical, radiofrequency, magnetic, motion signal, that is directed at the lumen of thestomach or esophagus and initiates the process. For example as food goesthrough the lumen of the GI tract a signal is sent, and when this isabsorbed, deflected or altered by food or luminal contents activates thesystem. Similarly a reflector could be placed opposite the signal andwhenever the reflector is blocked the system is activated. The sensorcan be current and voltage measurements on the stomach to measureparameters such as stomach impedance which correlates with start ofeating.

The sensor could be a infrared beam that is combined with spectroscopyto detect a change in tissue perfusion, such as an increase in oxygensaturation which correlates to increased arterial blood flow to thestomach when food arrives at the stomach and it is active.

The sensor could be other measure of increased blood flow to the stomachor other signal such as temperature change, change in local chemistry,which detect a subtle change in local environment.

The sensor 4 could also be placed in the arm or in a combination ofplaces and detect a motion or action that is consistent with bringingfood toward the GI tract. The sensor 4 could detect changes in saliva orother GI tract secretion that is produced with the onset of eating.

Once activated the system can be placed on and constrict the stomach ata steady rate controlled manner to a predetermined level. Alternatively,the sensor 4 can serve as a gradient and each time the system detectsfood the constrictor is tightened or an internal system is inflatedprogressively.

The system controller is equipped with a memory. The purpose is todetermine the number of times the system is activated. This informationcan be used to change speed of constriction or inflation, provideinformation for clinicians and alter the rate of emptying or any of theparameters of the system. The memory can also store dietary informationrelated to the output of sensor 4 or other sensors, for example a bloodsugar sensor, that are coupled to the internal controller 5. The memorycan function as an internal data base of information and data that canbe extracted by a physician utilizing the external controller 9.

In a preferred embodiment 100 the mechanism for progressive restrictionof the stomach is mechanical in nature and acts directly on the AGV totighten it or release it. Such mechanical action can be done for exampleby pulling one side of the strip 10 around the other part or inside theother part by use of a small motor as shown in FIG. 3. In FIG. 3 thestomach cross section is indicated by 20, the cushioning 21 can be asoft material or a sealed balloon. A small motor 23 acts on the AGV 22to reduce its diameter by pulling or releasing one end of the AGV inrelation to the other end of the AGV.

In another preferred embodiment 200 described in FIG. 4, the AGV itselfdoes not change in dimensions, only a balloon 36 on the inside of theAGV is changes its volume and pressure. In FIG. 4 the stomach crosssection is indicated by 32, the AGV is indicated by 30 with 33 being theconnection of the two ends of the AGV. A balloon 36 is connected to atube 34 having a piston 39 and a mechanism to push liquid through thetube and into said balloon 36. The inside 31 of the balloon 36 pushesagainst the stomach 32. The borders of the balloon are indicated by 31on the inside and 30 on the outside. The balloon 36 connects to the tube34 and a piston, and the balloon 36 and the tube 34 are filled with aliquid such as saline solution. A motor 35 acts on the piston andthereby increases or decreases the pressure in the balloon 36 andtherefore increases or decreases the diameter of the AGV on demand in aprogressive manner. In another embodiment the pushing can be done bycompressing a bellow filled with liquid.

In yet another embodiment 300 of the restrictive mechanism shown in FIG.5, the stomach 41 is encircled with an AGV 42 and a balloon 43 similarlyto embodiment 200. The balloon 43 is filled with liquid, such as salinesolution, and is connected via a tube 44 to a reservoir 45 and a pump46. The pump, controlled by the controller B 5, can pump the liquid intothe balloon and out of the balloon and increase or decrease the diameterof the stomach 41 to create a progressive restriction on the flow offood and relaxation of the stomach when the patient is not eating.

The system can be designed as a ring, helix or blanket. It could havecompartments that are activated at different or the same time. Thesystem could also be placed internally as a bezoar into the stomachanchored by an attachment to the gastric wall. Food would hit the sensorwhich would cause the inflation of the bezoar causing gastricdistension.

Similar to all the above, rate of inflation and deflation could bealtered based on feedback of the system or device history.

1. A method for treating overweight patients, comprising: applying arestrictive device to a part of a patient's stomach; and placing asensor and a controller inside the patient's body, the sensor configuredto sense initiation of eating, the controller configured toautomatically control the restrictive device in response to theinitiation of eating to progressively control the restrictive device tomimic what occurs when a person begins to eat, the controller configuredto move the restrictive device from a restricted state to a relaxedstate at a speed of relaxation to increase an opening inside thepatent's stomach, the controller configured to alter the speed ofrelaxation, wherein most of the time the restrictive device is in therelaxed state and the stomach is at its natural state.
 2. The method ofclaim 1 wherein the applying includes a plurality of restrictivedevices.
 3. The method of claim 1 wherein restriction of the restrictivedevice is initiated by a start of eating or other bodily functionsrelated to eating.
 4. The method of claim 1 wherein control of therestrictive device is performed with a mechanical ring shape having adiameter that is changed with a motor.
 5. The method of claim 1 whereincontrol of the restrictive device is performed with a piston pushingliquid in and out of a balloon inside the restrictive device.
 6. Themethod of claim 1 wherein control of the restrictive device is performedby a motor pushing liquid inside a bellow container in and out of aballoon inside the restrictive device.
 7. The method of claim 1 whereincontrol of the restrictive device is performed with liquid or gas storedin a reservoir in the body of the patient and pushed in and out of aballoon inside the restrictive device with a pump.
 8. The method ofclaim 1 wherein a battery supplies electrical power for changing adiameter of the restrictive device.
 9. The method of claim 1 wherein arechargeable battery within the body of the patient supplies electricalpower for changing a diameter of the restrictive device, and the batteryis charged with a remote charger located outside the body of thepatient.
 10. The method of claim 1 wherein the restrictive device iscontrolled by a control algorithm that can be changed from outside thebody of the patient via wireless communication.
 11. The method accordingto claim 1 wherein the sensor is configured to sense cessation of eatingand the controller is configured to relax the restrictive device inresponse to the sensor sensing the cessation of eating.
 12. The methodaccording to claim 11 wherein the controller is configured to determinewhether a delay should be introduced after the cessation of eating andbefore relaxing the restrictive device and introducing the delay when itis determined to be necessary.
 13. The method according to claim 1wherein the controller is configured to store event times associatedwith operation of the restrictive device including initiation of eating,cessation of eating, restriction of the restrictive device andrelaxation of the restrictive device.
 14. The method according to claim1 wherein a speed of restriction and the speed of relaxation are alteredbased upon feedback.
 15. The method according to claim 1 wherein acontrol algorithm that is customized for a particular patient controlsthe restrictive device.
 16. The method according to claim 1 wherein atthe initiation of eating the restrictive device is activated andrestricts one area of a gastric lumen and allows expansion anddistension of other areas to physically restrict the amount of food thatis eaten and to promote the satiety signals that are produced whendistension or increased pressure in the gastric lumen occurs.
 17. Anapparatus for treating overweight patients, comprising: a restrictivedevice which is adapted to be disposed on a part of a stomach; a sensorfor sensing initiation of eating; and a control system, responsive tothe sensor, for automatically controlling relaxation and restriction ofthe restrictive device, the control system configured to move therestrictive device from a relaxed state to a restricted state at a speedof restriction, the control system configured to alter the speed ofrestriction and to progressively control the restrictive device to mimicwhat occurs when a person begins to eat.
 18. The apparatus of claim 17which includes a plurality of restrictive devices.
 19. The apparatus ofclaim 17 wherein restriction of the restrictive device is initiated by astart of eating or other bodily functions related to eating.
 20. Theapparatus of claim 17 wherein control of the restrictive device isperformed with a mechanical ring shape having a diameter that is changedwith a motor.
 21. The apparatus of claim 17 wherein control of therestrictive device is performed with a piston pushing liquid in and outof a balloon inside the restrictive device.
 22. The apparatus of claim17 wherein control of the restrictive device is performed by a motorpushing liquid inside a bellow container in and out of a balloon insidethe restrictive device.
 23. The apparatus of claim 17 wherein control ofthe restrictive device is performed with liquid or gas adapted to bestored in a reservoir in the body of a patient and pushed in and out ofa balloon inside the restrictive device with a pump.
 24. The apparatusof claim 17 wherein a battery supplies electrical power for changing adiameter of the restrictive device.
 25. The apparatus of claim 17wherein a rechargeable battery supplies electrical power for changing adiameter of the restrictive device, and the battery is charged with aremote charger adapted to be located outside the body of a patienthaving the restrictive device.
 26. The apparatus according to claim 17wherein the sensor is adapted for placement in the mouth of a patient.27. The apparatus according to claim 17 wherein the sensor is adaptedfor placement on an extremity of a patient.
 28. The apparatus accordingto claim 17 wherein the sensor is adapted for placement on thegastrointestinal tract of a patient.
 29. The apparatus according toclaim 17 wherein the sensor is responsive to bodily actions selectedfrom the group comprising receptive relaxation of a stomach, salivasecretion, chewing, swallowing, secretion of hormones, changes in bloodglucose level, changes in heart rate variability or expansion of thestomach, or changes of electrical parameters of a stomach includingimpedance.
 30. The apparatus according to claim 17 wherein the sensor isresponsive to energy selected from the group comprising ultrasound,infrared, electrical, radio frequency or magnetic energy.
 31. Theapparatus according to claim 17 wherein the sensor is responsive to ameasure of increased blood flow to a stomach, temperature change, changein local chemistry, or a change in local environment.
 32. The apparatusaccording to claim 17 which further includes a memory for storinginformation related to operation of the restrictive device.
 33. Theapparatus according to claim 17 which further includes a memory forstoring information that can be extracted for external use.
 34. Theapparatus according to claim 33 wherein the information includes dietaryinformation.
 35. The apparatus according to claim 33 wherein theinformation includes blood sugar measurements.
 36. The apparatusaccording to claim 17 which includes a control algorithm that can bechanged from outside the body of a patient having the restrictive devicevia wireless communication.
 37. The apparatus according to claim 17wherein the sensor is configured to sense a cessation of eating and thecontrol system is configured to relax the restrictive device in responseto the sensing of the cessation of eating.
 38. The apparatus accordingto claim 37 wherein the control system is configured to determinewhether a delay should be introduced after the cessation of eating andbefore a relaxing of the restrictive device and introducing the delaywhen it is determined to be necessary.
 39. The apparatus according toclaim 17 wherein the control system is configured to store event timesassociated with operation of the restrictive device including initiationof eating, cessation of eating, restriction of the restrictive deviceand a relaxation of the restrictive device.
 40. The apparatus accordingto claim 17 wherein the control system is configured to alter the speedof restriction based upon feedback and a speed of relaxation based uponfeedback.
 41. The apparatus according to claim 17 wherein the controlsystem is controlled by a control algorithm that is customized for aparticular patient.
 42. The apparatus according to claim 17 wherein thecontrol system is configured to activate the restrictive device at aninitiation of eating and restrict one area of a gastric lumen, and allowexpansion and distention of other areas to physically restrict theamount of food that is eaten and to promote the satiety signals that areproduced when distension or increased pressure in the gastric lumenoccurs.
 43. A device that augments the natural response of a body toeating by reducing food intake, which comprises a sensor for sensinginitiation of eating, an electronically controlled restrictive device,and a controller, that is responsive to the sensor, for progressivelycausing the electronically controlled restrictive device to physicallyrestrict and relax part of a gastrointestinal (GI) tract, in order tomimic what occurs when a person begins to eat, and to control andregulate flow of food, as food is ingested, the controller configured tomove the electronically controlled restrictive device from a restrictedstate to a relaxed state at a speed of relaxation and to alter the speedof relaxation.
 44. A method for augmenting the natural response of abody to eating by reducing food intake, comprising: applying arestrictive device to a part of a patient's stomach; and placing asensor and a controller inside the patient's body, the sensor configuredto sense initiation of eating, the controller configured toelectronically control the restrictive device, and progressively causethe restrictive device to physically restrict and relax part of thegastrointestinal (GI) tract, in order to mimic what occurs when a personbegins to eat, and to control and regulate the flow of food, as food isingested, the controller configured to move the restrictive device froma relaxed state to a restricted state at a speed of restriction and toalter the speed of restriction.